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Eisai Inc. (ESALF.PK) Slams German Decision on Fycompa; Takeda Pharmaceutical Co. Ltd. (TKPYY) Files Vedolizumab With European Medicines Agency

3/11/2013 8:44:09 AM

The German Federal Joint Committee (G-BA), the decision-making body of the self-governing medical system in Germany, has that it considers the additional benefit of Japanese drug major Eisai’s (TYO: 4523) epilepsy drug Fycompa (perampanel) unproven when compared to two other treatments as defined by the G-BA. CS PharmaValues NPV Analysts at Credit Suisse have a net present value for Fycompa in Europe is 97.88 yen per share (3% of total) for Eisai. The decision follows the German Institute for Quality and Efficiency in Health Care (IQWiG) assessment saying that the benefit of perampanel is unproven based on methodological grounds (The Pharma Letter December 19, 2012). Perampanel is the first in an entirely new class of innovative treatment for uncontrolled partial epilepsy with a novel mechanism of action that is different from all other anti-epileptic drugs (AEDs). Eisai says it “is appalled by the G-BA’s ruling.” The company believes that the G-BA failed to adequately interpret the proven patient-relevant benefits substantiated in the submitted benefit dossier and to responsibly recognize the innovative nature of the new drug in a clinical setting with a highly unmet medical need. Eisai says it diligently developed the benefit dossier following scientific advice from the G-BA. In addition, it provided further evidence in a written statement preceding the G-BA Oral Hearing on January 29, 2013, and re-iterated the additional benefit perampanel provides to patients, especially to patients who require new options to help manage their seizures. Eisai maintains that the submitted benefit dossier contains a methodologically robust comparative analysis against the appropriate comparative therapy, lamotrigine, as defined by the G-BA. On the advice of the G-BA, Eisai also performed an indirect analysis using published clinical data for lamotrigine. Eisai strongly believes that it has provided compelling evidence to demonstrate the additional benefit of perampanel.

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